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Last Updated: December 23, 2024

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SYFOVRE Drug Patent Profile


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When do Syfovre patents expire, and when can generic versions of Syfovre launch?

Syfovre is a drug marketed by Apellis Pharms and is included in one NDA. There are eleven patents protecting this drug.

This drug has one hundred and eighty patent family members in twenty-six countries.

The generic ingredient in SYFOVRE is pegcetacoplan. One supplier is listed for this compound. Additional details are available on the pegcetacoplan profile page.

DrugPatentWatch® Generic Entry Outlook for Syfovre

Syfovre will be eligible for patent challenges on May 14, 2025. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 15, 2033. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for SYFOVRE
International Patents:180
US Patents:11
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Drug Prices: Drug price information for SYFOVRE
What excipients (inactive ingredients) are in SYFOVRE?SYFOVRE excipients list
DailyMed Link:SYFOVRE at DailyMed
Drug patent expirations by year for SYFOVRE
Drug Prices for SYFOVRE

See drug prices for SYFOVRE

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for SYFOVRE
Generic Entry Date for SYFOVRE*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;INTRAVITREAL

*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.

Pharmacology for SYFOVRE
Drug ClassComplement Inhibitor
Mechanism of ActionComplement Inhibitors

US Patents and Regulatory Information for SYFOVRE

SYFOVRE is protected by fourteen US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of SYFOVRE is ⤷  Subscribe.

This potential generic entry date is based on patent ⤷  Subscribe.

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
Apellis Pharms SYFOVRE pegcetacoplan SOLUTION;INTRAVITREAL 217171-001 Feb 17, 2023 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y Y ⤷  Subscribe
Apellis Pharms SYFOVRE pegcetacoplan SOLUTION;INTRAVITREAL 217171-001 Feb 17, 2023 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Apellis Pharms SYFOVRE pegcetacoplan SOLUTION;INTRAVITREAL 217171-001 Feb 17, 2023 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Apellis Pharms SYFOVRE pegcetacoplan SOLUTION;INTRAVITREAL 217171-001 Feb 17, 2023 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Apellis Pharms SYFOVRE pegcetacoplan SOLUTION;INTRAVITREAL 217171-001 Feb 17, 2023 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Apellis Pharms SYFOVRE pegcetacoplan SOLUTION;INTRAVITREAL 217171-001 Feb 17, 2023 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for SYFOVRE

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Swedish Orphan Biovitrum AB (publ) Aspaveli pegcetacoplan EMEA/H/C/005553
Aspaveli is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who are anaemic after treatment with a C5 inhibitor for at least 3 months.
Authorised no no yes 2021-12-13
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for SYFOVRE

When does loss-of-exclusivity occur for SYFOVRE?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 13344462
Patent: Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods
Estimated Expiration: ⤷  Subscribe

Patent: 18247243
Patent: Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods
Estimated Expiration: ⤷  Subscribe

Patent: 20260435
Patent: Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods
Estimated Expiration: ⤷  Subscribe

Patent: 23200929
Patent: Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods
Estimated Expiration: ⤷  Subscribe

Brazil

Patent: 2015011244
Patent: ANÁLOGOS DE COMPSTATINA DE AÇÃO PROLONGADA, MÉTODO DE FABRICAÇÃO E USO DOS MESMOS, BEM COMO COMPOSIÇÃO DE QUALIDADE FARMACÊUTICA
Estimated Expiration: ⤷  Subscribe

Canada

Patent: 91673
Patent: ANALOGUES DE LA COMPSTATINE REACTIFS AUX CELLULES, A LONGUE DUREE D'ACTION OU CIBLES ET COMPOSITIONS ET METHODES ASSOCIEES (CELL-REACTIVE, LONG-ACTING, OR TARGETED COMPSTATIN ANALOGS AND RELATED COMPOSITIONS AND METHODS)
Estimated Expiration: ⤷  Subscribe

China

Patent: 5051057
Patent: Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods
Estimated Expiration: ⤷  Subscribe

Patent: 0882376
Patent: 细胞反应性的、长效的或靶向的坎普他汀类似物及相关组合物和方法 (Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods)
Estimated Expiration: ⤷  Subscribe

Croatia

Patent: 0211342
Estimated Expiration: ⤷  Subscribe

Cyprus

Patent: 24474
Estimated Expiration: ⤷  Subscribe

Patent: 22015
Estimated Expiration: ⤷  Subscribe

Denmark

Patent: 20201
Estimated Expiration: ⤷  Subscribe

Patent: 60033
Estimated Expiration: ⤷  Subscribe

European Patent Office

Patent: 20201
Patent: ANALOGUES DE LA COMPSTATINE À LONGUE DURÉE D'ACTION ET COMPOSITIONS ET MÉTHODES ASSOCIÉES (LONG-ACTING COMPSTATIN ANALOGS AND RELATED COMPOSITIONS AND METHODS)
Estimated Expiration: ⤷  Subscribe

Patent: 60033
Patent: ANALOGUES DE LA COMPSTATINE À LONGUE DURÉE D'ACTION ET COMPOSITIONS ET MÉTHODES ASSOCIÉES (LONG-ACTING COMPSTATIN ANALOGS AND RELATED COMPOSITIONS AND METHODS)
Estimated Expiration: ⤷  Subscribe

Patent: 29206
Patent: ANALOGUES DE LA COMPSTATINE À LONGUE DURÉE D'ACTION ET COMPOSITIONS ET MÉTHODES ASSOCIÉES (LONG-ACTING COMPSTATIN ANALOGS AND RELATED COMPOSITIONS AND METHODS)
Estimated Expiration: ⤷  Subscribe

France

Patent: C1025
Estimated Expiration: ⤷  Subscribe

Hong Kong

Patent: 15445
Patent: 細胞反應性的、長效的或靶向的坎普他汀類似物及相關組合物和方法 (CELL-REACTIVE, LONG-ACTING, OR TARGETED COMPSTATIN ANALOGS AND RELATED COMPOSITIONS AND METHODS)
Estimated Expiration: ⤷  Subscribe

Patent: 17336
Patent: 細胞反應性的、長效的或靶向的坎普他汀類似物及相關組合物和方法 (CELL-REACTIVE, LONG-ACTING, OR TARGETED COMPSTATIN ANALOGS AND RELATED COMPOSITIONS AND METHODS)
Estimated Expiration: ⤷  Subscribe

Hungary

Patent: 55564
Estimated Expiration: ⤷  Subscribe

Patent: 200026
Estimated Expiration: ⤷  Subscribe

Israel

Patent: 6004
Patent: אנלוגים של קומפסטאטין המגיבים בתא, פועלים בטווח ארוך או מיועדים למטרה ותכשירים קשורים ושיטות (Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods)
Estimated Expiration: ⤷  Subscribe

Japan

Patent: 73167
Estimated Expiration: ⤷  Subscribe

Patent: 93871
Estimated Expiration: ⤷  Subscribe

Patent: 41271
Estimated Expiration: ⤷  Subscribe

Patent: 16505527
Patent: 細胞反応性、長時間作用型または標的化コンプスタチン類似体ならびに関係する組成物および方法
Estimated Expiration: ⤷  Subscribe

Patent: 19070011
Patent: 細胞反応性、長時間作用型または標的化コンプスタチン類似体ならびに関係する組成物および方法 (CELL-REACTIVE-, LONG-ACTING- OR TARGETED COMPSTATIN ANALOGS, RELATED COMPOSITIONS AND METHODS)
Estimated Expiration: ⤷  Subscribe

Patent: 21107441
Patent: 細胞反応性、長時間作用型または標的化コンプスタチン類似体ならびに関係する組成物および方法 (CELL-REACTIVE, LONG-ACTING OR TARGETED COMPSTATIN ANALOGS AND RELATED COMPOSITIONS AND METHODS)
Estimated Expiration: ⤷  Subscribe

Patent: 22120193
Patent: 細胞反応性、長時間作用型または標的化コンプスタチン類似体ならびに関係する組成物および方法
Estimated Expiration: ⤷  Subscribe

Patent: 24056923
Patent: 細胞反応性、長時間作用型または標的化コンプスタチン類似体ならびに関係する組成物および方法 (CELL-REACTIVE, LONG-ACTING, OR TARGETED COMPSTATIN ANALOGS AND RELATED COMPOSITIONS AND METHODS)
Estimated Expiration: ⤷  Subscribe

Lithuania

Patent: 2022010
Estimated Expiration: ⤷  Subscribe

Patent: 60033
Estimated Expiration: ⤷  Subscribe

Mexico

Patent: 6404
Patent: ANALOGOS DE COMPSTATINA DE CELULA REACTIVA, DE ACCIÓN PROLONGADA U OBJETIVOS Y COMPOSICIONES Y METODOS RELACIONADOS. (CELL-REACTIVE, LONG-ACTING, OR TARGETED COMPSTATIN ANALOGS AND RELATED COMPOSITIONS AND METHODS.)
Estimated Expiration: ⤷  Subscribe

Patent: 15006154
Patent: ANALOGOS DE COMPSTATINA DE CELULA REACTIVA, DE ACCIÓN PROLONGADA U OBJETIVOS Y COMPOSICIONES Y METODOS RELACIONADOS. (CELL-REACTIVE, LONG-ACTING, OR TARGETED COMPSTATIN ANALOGS AND RELATED COMPOSITIONS AND METHODS.)
Estimated Expiration: ⤷  Subscribe

Patent: 19007709
Patent: ANALOGOS DE COMPSTATINA DE CELULA REACTIVA, DE ACCION PROLONGADA U OBJETIVOS Y COMPOSICIONES Y METODOS RELACIONADOS. (CELL-REACTIVE, LONG-ACTING, OR TARGETED COMPSTATIN ANALOGS AND RELATED COMPOSITIONS AND METHODS.)
Estimated Expiration: ⤷  Subscribe

Netherlands

Patent: 1178
Estimated Expiration: ⤷  Subscribe

Norway

Patent: 22017
Estimated Expiration: ⤷  Subscribe

Poland

Patent: 20201
Estimated Expiration: ⤷  Subscribe

Patent: 60033
Estimated Expiration: ⤷  Subscribe

Portugal

Patent: 20201
Estimated Expiration: ⤷  Subscribe

Patent: 60033
Estimated Expiration: ⤷  Subscribe

Russian Federation

Patent: 05215
Patent: КЛЕТОЧНО-РЕАКТИВНЫЕ АНАЛОГИ КОМПСТАТИНА, АНАЛОГИ КОМПСТАТИНА ДЛИТЕЛЬНОГО ДЕЙСТВИЯ ИЛИ АНАЛОГИ КОМПСТАТИНА НАЦЕЛЕННОГО ДЕЙСТВИЯ И СВЯЗАННЫЕ С НИМИ КОМПОЗИЦИИ И СПОСОБЫ (CELL-REACTIVE COMPOSTATIN ANALOGUES, LONG-ACTING COMPSTATIN ANALOGUES OR COMPUTED EFFECT ANALOGUES OF TARGETED ACTION AND RELATED COMPOSITIONS AND METHODS)
Estimated Expiration: ⤷  Subscribe

Patent: 15119165
Patent: КЛЕТОЧНО-РЕАКТИВНЫЕ АНАЛОГИ КОМПСТАТИНА, АНАЛОГИ КОМПСТАТИНА ДЛИТЕЛЬНОГО ДЕЙСТВИЯ ИЛИ АНАЛОГИ КОМПСТАТИНА НАЦЕЛЕННОГО ДЕЙСТВИЯ, И СВЯЗАННЫЕ С НИМИ КОМПОЗИЦИИ И СПОСОБЫ
Estimated Expiration: ⤷  Subscribe

Serbia

Patent: 243
Patent: ANALOZI KOMPSTATINA SA PRODUŽENIM TRAJANJEM DEJSTVA I NJIHOVE KOMPOZICIJE I POSTUPCI (LONG-ACTING COMPSTATIN ANALOGS AND RELATED COMPOSITIONS AND METHODS)
Estimated Expiration: ⤷  Subscribe

Slovenia

Patent: 60033
Estimated Expiration: ⤷  Subscribe

Spain

Patent: 80674
Estimated Expiration: ⤷  Subscribe

Patent: 79430
Estimated Expiration: ⤷  Subscribe

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

See the table below for additional patents covering SYFOVRE around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 2707384 ANALOGUES DE LA COMPSTATINE CIBLÉS, À LONGUE DURÉE D'ACTION, RÉACTIFS AUX CELLULES, ET LEURS UTILISATIONS (CELL-REACTIVE, LONG-ACTING, OR TARGETED COMPSTATIN ANALOGS AND USES THEREOF) ⤷  Subscribe
Japan 2016028081 眼の障害のための注射可能複合療法 (INJECTABLE COMBINATION THERAPY FOR EYE DISORDERS) ⤷  Subscribe
Russian Federation 2013149956 КЛЕТОЧНО-РЕАКТИВНЫЕ АНАЛОГИ КОМПСТАТИНА, АНАЛОГИ КОМПСТАТИНА ДЛИТЕЛЬНОГО ДЕЙСТВИЯ ИЛИ АНАЛОГИ КОМПСТАТИНА НАЦЕЛЕННОГО ДЕЙСТВИЯ И ИХ ПРИМЕНЕНИЕ ⤷  Subscribe
Israel 237915 שיטה להכנת אנלוים חזקים של קומפסטטין ושימוש בהם להכנת תרופה לעיכוב הפעלת מערכת המשלים (A method of making potent compstatin analogs and use therof for preparing a medicament for inhibiting complement activation) ⤷  Subscribe
Japan 2013531030 ⤷  Subscribe
Denmark 2920201 ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SYFOVRE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3660033 122022000034 Germany ⤷  Subscribe PRODUCT NAME: PEGCETACOPLAN; REGISTRATION NO/DATE: EU/1/21/1595 20211213
3660033 PA2022010 Lithuania ⤷  Subscribe PRODUCT NAME: PEGCETACOPLANAS ; REGISTRATION NO/DATE: EU/1/21/1595 20211213
3660033 2022C/522 Belgium ⤷  Subscribe PRODUCT NAME: PEGCETACOPLAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1595 20211214
3660033 CR 2022 00023 Denmark ⤷  Subscribe PRODUCT NAME: PEGCETACOPLAN; REG. NO/DATE: EU/1/21/1595 20211214
3660033 2022017 Norway ⤷  Subscribe PRODUCT NAME: PEGCETACOPLAN; REG. NO/DATE: EU/1/21/1595 20211216
3660033 301178 Netherlands ⤷  Subscribe PRODUCT NAME: PEGCETACOPLAN; REGISTRATION NO/DATE: EU/1/21/1595 20211214
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

SYFOVRE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for SYFOVRE

Introduction

SYFOVRE, developed by Apellis Pharmaceuticals, is a groundbreaking drug approved for the treatment of geographic atrophy (GA), a form of vision loss associated with age-related macular degeneration. Since its launch, SYFOVRE has demonstrated robust market performance and significant financial growth.

Market Leadership in Geographic Atrophy

SYFOVRE has established itself as the market leader in the treatment of GA. In the second quarter of 2024, it delivered over 84,000 doses to physician practices, including more than 79,000 commercial vials and approximately 5,000 samples. This trend continued into the third quarter, with over 88,500 doses delivered, comprising around 84,500 commercial vials and 4,000 samples[1][2].

Revenue Growth

The financial performance of SYFOVRE has been impressive. In the second quarter of 2024, it generated $154.6 million in U.S. net product revenue, contributing significantly to Apellis Pharmaceuticals' total revenue of $199.7 million for the quarter. This represents a substantial increase from the second quarter of 2023, when SYFOVRE revenue was $67.3 million[1][3].

In the third quarter of 2024, SYFOVRE continued its growth trajectory, with U.S. net product revenue of $152.0 million, despite a slight decline in net selling price due to increased gross-to-net adjustments. This still marked a 7% quarter-over-quarter growth in commercial vial demand[2][5].

Total Sales and Administration

Since its launch, SYFOVRE has achieved over $0.5 billion in sales, with more than 330,000 injections estimated to have been administered through June 2024, and over 420,000 by September 2024, including clinical trials. This rapid adoption underscores the drug's strong market position and the significant need for effective GA treatments[1][3].

Formulary Inclusions and Payer Coverage

SYFOVRE has gained favorable formulary positions, which are crucial for its continued success. Effective July 1, 2024, two large national pharmacy benefit managers made SYFOVRE the preferred product on their commercial formularies. Additionally, starting January 1, 2025, a large Medicare Advantage plan will make SYFOVRE the only preferred product on its formulary[1][2].

Clinical and Safety Profile

Despite some initial concerns about side effects, particularly occlusive retinal vasculitis, Apellis has maintained that these cases are rare, affecting about 0.01% of injections. The company has continued to update doctors on new cases and has indicated that a faulty needle might be related to the issue. This transparency and the drug's overall efficacy profile have helped in maintaining physician confidence and patient demand[4].

European Market and Regulatory Updates

Apellis has been working to expand SYFOVRE's reach into the European market. However, the company faced a negative opinion from the Committee for Medicinal Products for Human Use (CHMP) in June and September 2024, which has delayed the marketing authorization application. Despite this, Apellis remains committed to re-examining the application and expects a final decision in the fourth quarter of 2024[1][2].

Financial Projections and Cash Flow

Apellis Pharmaceuticals is optimistic about its financial future, driven largely by SYFOVRE's performance. The company has a clear line of sight to positive cash flow and is strengthening its balance sheet. With cash and cash equivalents of $396.9 million as of September 30, 2024, Apellis is confident that its projected revenues and cash will be sufficient to fund operations until it reaches positive cash flow[3][5].

Expansion into New Indications

In addition to its success in GA, Apellis is exploring new indications for SYFOVRE. The company is on track to file a supplemental New Drug Application (sNDA) seeking approval for pegcetacoplan in C3G (Complement 3 glomerulopathy) and primary IC-MPGN (Immune Complex Membranoproliferative Glomerulonephritis) based on positive Phase 3 VALIANT study results. This expansion could further bolster SYFOVRE's market presence and revenue potential[5].

Competitive Position

Apellis's contracting strategies and the drug's safety profile are expected to support its competitive position. The company's focus on direct-to-consumer campaigns and the favorable view of SYFOVRE's clinical profile by physicians are also key factors in driving growth in new patient starts[3].

Challenges and Future Outlook

While SYFOVRE faces some challenges, such as the recent side effect concerns and regulatory hurdles in Europe, the drug's overall performance and market demand remain strong. Apellis's strategic focus on SYFOVRE and its expansion into new indications position the company for continued growth and market dominance.

Key Takeaways

  • Market Leadership: SYFOVRE is the leading treatment for geographic atrophy, delivering over 84,000 doses in Q2 2024 and over 88,500 doses in Q3 2024.
  • Revenue Growth: Generated $154.6 million in Q2 2024 and $152.0 million in Q3 2024 in U.S. net product revenue.
  • Formulary Inclusions: Preferred product on several major formularies, including a large Medicare Advantage plan starting January 1, 2025.
  • Clinical Profile: Despite rare side effects, the drug's efficacy and safety profile remain strong.
  • European Market: Facing regulatory delays but expecting a final decision in Q4 2024.
  • Financial Projections: Clear line of sight to positive cash flow with sufficient projected revenues and cash.

FAQs

What is SYFOVRE used for?

SYFOVRE is used for the treatment of geographic atrophy (GA), a form of vision loss associated with age-related macular degeneration.

How has SYFOVRE performed financially?

SYFOVRE generated $154.6 million in U.S. net product revenue in Q2 2024 and $152.0 million in Q3 2024, contributing significantly to Apellis Pharmaceuticals' total revenue.

What are the side effects associated with SYFOVRE?

SYFOVRE has been linked to rare cases of occlusive retinal vasculitis, affecting about 0.01% of injections. However, most cases have been reported as recoverable.

Is SYFOVRE covered by major formularies?

Yes, SYFOVRE has been included as a preferred product on several major formularies, including two large national pharmacy benefit managers and a large Medicare Advantage plan starting January 1, 2025.

What are Apellis's plans for expanding SYFOVRE's indications?

Apellis plans to file an sNDA seeking approval for pegcetacoplan in C3G and primary IC-MPGN based on positive Phase 3 VALIANT study results.

Sources

  1. Apellis Pharmaceuticals Reports Second Quarter 2024 Financial Results - Apellis Pharmaceuticals.
  2. Apellis Pharmaceuticals Reports Third Quarter 2024 Financial Results - Apellis Pharmaceuticals.
  3. Earnings call: Apellis Pharmaceuticals reports growth and market confidence - Investing.com.
  4. Apellis sales numbers show steady demand for new eye drug - Biopharma Dive.
  5. Apellis Pharmaceuticals Reports Third Quarter 2024 Financial Results - GlobeNewswire.

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