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Date: 2017-09-28

Type of information: Product launch

Product name: Jetrea®

Compound: ocriplasmin

Therapeutic area: Ophtalmological diseases

Action mechanism:

  • protein. Ocriplasmin is a truncated form of the human serine protease plasmin that retains its enzymatic properties. This small molecule has been designed specifically for use in the eye. It is believed to primarily target the fibronectin, laminin, and type IV collagen fibers that adhere the vitreous to the retina.By dissolving these proteins, ocriplasmin releases the traction, and helps to complete the detachment of the vitreous from the macula.It works by separating the vitreous humour from the macula, and helping to close the macular hole if one is present which may decrease the symptoms caused by VMT. Ocriplasmin is administered through a one-time, single intravitreal injection.
  • Alcon, a division of Novartis, acquired the rights to commercialize Jetrea® outside the United States in March 2012. ThromboGenics retains the rights to commercialize the drug in the US.
  • On March 16, 2012, Thrombogenics has entered into an agreement with Alcon for the commercialization of ocriplasmin in all markets outside the U.S. Under the agreement ThromboGenics will have a strategic and focused operational role in the commercialization of ocriplasmin in the five largest European markets, enabling it to build the foundation for an expanding ophthalmology franchise. In addition to the commercial introduction of ocriplasmin in markets outside the U.S., the agreement specifies that Alcon and ThromboGenics will work together, and share the costs, to further develop new clinical applications of the product that the companies will introduce in their respective territories.  Alcon plans to introduce ocriplasmin in more than 40 countries worldwide.

Company: Thrombogenics (Belgium) - Alcon, a division of Novartis (Switzerland)

Disease:

  • symptomatic vitreomacular adhesion (VMA)
  • vitreomacular traction (VMT)

Latest news:

  • • On September 28, 2017, ThromboGenics announced that it has successfully introduced a new 'Already-Diluted' formulation of Jetrea® in the US. The new formulation is designed to eliminate the preparatory dilution steps before injection. At the point of administration into the eye, the strength, potency, composition and pharmaceutical form of the already-diluted formulation remain identical to the currently available formulation after dilution..
  • • On June 8, 2016, ThromboGenics announced that the Office of Biotechnology Products of the FDA has approved a new already-diluted formulation of its Jetrea® (ocriplasmin). This new formulation eliminates the current preparatory dilution steps prior to injection. At the point of administration into the eye, the strength, potency, composition and pharmaceutical form of the already-diluted formulation remain identical to the currently available formulation after dilution. ThromboGenics plans to launch the already-diluted formulation of Jetrea® in the first half of 2017.
  • • On March 16, 2015, ThromboGenics announced that Jetrea® (ocriplasmin) has gained approval in Brazil for the treatment of adults with vitreomacular traction, including when associated with macular hole of diameter less than or equal to 400 microns.
  • • On January 15, 2015, Alcon announced that the Swedish Dental and Pharmaceutical Benefits Agency (Tandvårds- och läkemedelsförmånsverket –TLV) recommends Jetrea® (ocriplasmin) as a clinically proven and cost-effective treatment option for patients in Sweden suffering from vitreomacular traction including when associated with macular hole of less than or equal to 400 microns, with no epiretinal membrane. TLV concluded its assessment based on health economic analysis showing that Jetrea® is cost-effective for the treatment of VMT patients, with and without macular hole of less than or equal to 400 microns, with no ERM.
  • • On February 12, 2015, ThromboGenics announces that Jetrea® (ocriplasmin) has gained approval in Argentina and Israel. In both countries, Jetrea® has been indicated for the treatment of adults with vitreomacular traction (VMT) including when associated with macular hole of diameter less than or equal to 400 microns.
  • • On October 6, 2014, ThromboGenics announced that Australia's Therapeutic Goods Administration has approved Jetrea® (ocriplasmin) for the treatment of adults with vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns.
  • • On September 8, 2014, ThromboGenics announced that Jetrea® (ocriplasmin) has been approved in South Korea for the treatment of adults with symptomatic vitreomacular adhesion (VMA) including when associated with macular hole of diameter less than or equal to 400 microns. South Korea is the fourth country in Asia to grant Jetrea® approval. The product has already gained approval in Malaysia, Singapore and Taiwan.
  • • On September 1, 2014, ThromboGenics announced that the Spanish Ministry of Health has approved the reimbursement of Jetrea® (ocriplasmin) for the treatment of adults with vitreomacular traction, including when associated with macular hole of diameter less than or equal to 400 microns. Jetrea® will be included in the national list of available reimbursed products from September, at a regional and hospital level.
  • • On August 11, 2014, ThromboGenics announced that the Scottish Medicines Consortium (SMC) has issued a positive recommendation for the use of Jetrea® (ocriplasmin) for the treatment of adults with vitreomacular traction, including when associated with macular hole of diameter less than or equal to 400 microns. This positive recommendation represents a reversal of the original SMC decision made in August 2013 and results from the submission of further data highlighting the economic value of Jetrea® when used to treat adults with VMT. The SMC's decision now allows the use and reimbursement of Jetrea® in Scotland.
  • • On July 1, 2014, ThromboGenics announced that Jetrea® (ocriplasmin) has been approved in Uruguay for the treatment of adults with vitreomacular traction, including when associated with macular hole of diameter less than or equal to 400 microns. Alcon will be responsible for the launch of the drug in Uruguay.
  • • On April 17, 2014, ThromboGenics has announces that Jetrea® (ocriplasmin) has been approved in Malaysia for the treatment of adults with vitreomacular traction, including when associated with macular hole of diameter less than or equal to 400 microns. The approval, the first in Asia, was gained following a Priority Review that was granted in September 2013.
  • • On March 18, 2014, ThromboGenics has announced that Swissmedic has approved Jetrea® (ocriplasmin) for the treatment of adults with vitreomacular traction, including when associated with macular hole of diameter less than or equal to 400 microns. Alcon will be responsible for the launch of the drug in Switzerland.
  • • On July 3, 2014, ThromboGenics announced that Jetrea® (ocriplasmin) has been approved in Singapore for the treatment of adults with vitreomacular traction, including when associated with macular hole of diameter less than or equal to 400 microns. Singapore is the second country in Asia to grant Jetrea® approval, following Malaysia in April. ThromboGenics' partner Alcon will be responsible for the launch of the drug in Singapore.
  • • On March 17, 2014, Thrombogenics has announced that US sales of Jetrea®  were €20.2 million in 2013, with close to 7000 patients treated. The company also said that it received a total of €90 million in milestone payments from Alcon following the approval and first launch of Jetrea® in Europe.
  • • On January 16, 2014, ThromboGenics has announced that the Transparency Commission (“Commission de la Transparence” or CT) of the French National Health Authority (“Haute Autorité de Santé” or HAS) has issued a positive opinion for the reimbursement and hospital listing of Jetrea® by the French National Health Insurance. The CT recommends Jetrea®for the treatment of adult patients with vitreomacular traction, including when associated with macular hole of diameter less than or equal to 400 microns, for whom symptomatology does not require immediately a vitrectomy at the earlier stage of this disease.
  • • On December 27, 2013, ThromboGenics has announced that Jetrea® has received a positive Common Drug Review (CDR) in Canada. The Common Drug Review, which is carried out by the Canadian Agency for Drugs and Technologies in Health (CADTH), is a pan-Canadian process for conducting objective, rigorous reviews of the clinical, cost-effectiveness, and patient evidence for drugs. CDR also provides formulary listing recommendations to Canada’s publicly funded drug plans (except Quebec).
  • • On December 3, 2013, ThromboGenics has announced that CMS (Center for Medicare and Medicaid Services) has published the permanent HCPCS (Healthcare Common Procedure Coding System) code for Jetrea® (ocriplasmin) J7316. The permanent J-Code for Jetrea® will become effective 1 January 2014. The absence of a HCPCS code for Jetrea® has meant that US physicians have had to manually submit Jetrea® claims to payers following their use of this novel treatment for symptomatic VMA (vitreomacular adhesion), said Thrombogenics. This has led to delays in reimbursement, and certain inefficiencies in use of financial working capital at a retina practice management level. The permanent J-Code will streamline the reimbursement process for retina practices and instil higher reimbursement confidence. Recent market research conducted by ThromboGenics has highlighted that the lack of a permanent J-Code is having an adverse impact on the uptake of Jetrea®.
  • • On November 20, 2013, ThromboGenics has announced that its partner Alcon has launched Jetrea® (ocriplasmin) for the treatment of symptomatic vitreomacular adhesion in Canada.
  • • On October 23, 2013, Alcon and Thrombogenics have announced that the National Institute for Health and Care Excellence (NICE) has recommended Jetrea® (ocriplasmin) as a clinically and cost-effective treatment option for eligible patients suffering from vitreomacular traction including when associated with macular hole. With this final NICE guidance, Jetrea® is now recommended for use within the National Health Service (NHS) in England and Wales as the first and only pharmacological treatment for this sight-threatening eye condition.
  • • On October 17, 2013, ThromboGenics has announced that the Final Early Benefit Assessment from the German Federal Joint Committee (G-BA) has concluded that Jetrea® (ocriplasmin) demonstrates significant added benefit for vitreomacular traction patients with mild and moderate symptoms when compared with existing comparative treatment (watchful waiting). Since the introduction of the early benefit assessment procedure in Germany in January 2011, G-BA has assessed more than sixty innovative new drugs. Jetrea® is to-date one of only six innovative medicines appraised by G-BA to provide significant additional therapeutic benefits for patients. G-BA’s final guidance confirms the recommendation made by the German Institute for Quality and Efficiency in Health Care (IQWiG) in August 2013.
  • • On September 2, 2013, ThromboGenics has announced that the UK’s National Institute for Health and Care Excellence (NICE) has confirmed, in its Final Appraisal Determination (FAD), its recommendation that Jetrea® (ocriplasmin) is an innovative new treatment and should be reimbursed within the National Health Service (NHS) in England and Wales. In its Final Appraisal Determination, NICE for the first time also characterized metamorphopsia as a ‘severe and distressing’ symptom with its impact on the patient being comparable  to a loss of 2 lines in visual acuity. As a result, NICE not only recommends full reimbursement of Jetrea® for patients with VMT and FTMH, smaller or equal to 400 microns, it also recommends reimbursement for those VMT patients with early stage VMT symptoms including  metamorphopsia.
  • • On August 16, 2013, ThromboGenics has announced that Health Canada has approved Jetrea® (ocriplasmin) for the treatment of symptomatic vitreomacular adhesion. The priority review of the New Drug Submission for Jetrea® in Canada was conducted within 180 calendar days.
  • • On August 2, 2013, ThromboGenics  has announced that the German Institute for Quality and Efficiency in Health Care (IQWiG) has confirmed that Jetrea® (ocriplasmin) demonstrates major/ significant added value in VMT patients with mild / moderately severe symptoms compared with existing comparative treatment, when treating vitreomacular traction including when associated with a macular hole of less than or equal to 400 microns. IQWiG recognizes that the data submitted by ThromboGenics in the course of the value assessment provides an indication (Hinweis) for a major added value for vitreomacular traction patients with mild symptoms and a significant added value for patients with moderately severe symptoms. Since the introduction of the Early Benefit Assessment in Germany in January 2011, this is the very first time that IQWiG confirms an indication for a major added value (Hinweis auf einen erheblichen Zusatznutzen) for an innovative new drug substance. Earlier this year, Jetrea® was classified as a breakthrough innovation, the highest rating in the so-called ‘Fricke and Klaus' assessment. This assessment evaluates how innovative the mechanism of action of a new medicine is compared to existing therapies available in Germany.
  • • On June 12, 2013, ThromboGenics has announced that the UK’s National Institute for Health and Care Excellence (NICE) has provisionally recommended Jetrea® (ocriplasmin) for reimbursement within the National Health Service. The NICE Appraisal Consultation Document (ACD) initially recommends Jetrea® as an option for treating vitreomacular traction in adults, including when associated with a macular hole of less than or equal to 400 microns, when patients have severe symptoms and an epiretinal membrane is not present. After publication of the ACD, NICE invites formal consultees, commentators and the general public to comment on the ACD. After considering these comments, the Committee then finalizes its recommendations and submits them to NICE in the form of a Final Appraisal Determination (FAD). The final NICE guidance on Jetrea® is expected in the third quarter of 2013.
  • • On May 27, 2013, ThromboGenics has announced that its partner Alcon has launched Jetrea® in Denmark and Sweden.
  • • On May 2, 2013,  ThromboGenics has announced that its partner Alcon has launched Jetrea® in Germany. Since May 1st, 2013, Jetrea® is listed in the "Lauer-Taxe" (Große Deutsche Spezialitätentaxe) with an ex-factory price of €3,078.
  • • On April 11, 2013, ThromboGenics has announced that its partner Alcon has launched Jetrea® (ocriplasmin) in the UK,. The first sale by Alcon triggers a €45 million milestone payment to ThromboGenics. Jetrea® is currently undergoing a single technology appraisal (STA) by the National Institute for Health and Care Excellence (NICE) as part of the process to gain reimbursement when used by the UK National Health Service. The outcome of the STA, in the form of NICE guidance, is expected in the final quarter of 2013.
  • • On March 15, 2013, ThromboGenics has announced that the European Commission has approved Jetrea® (ocriplasmin) in the European Union.for the treatment of vitreomacular traction, including when associated with macular hole of diameter less than or equal to 400 microns. The EU approval triggers a €45 million milestone payment to ThromboGenics from its partner Alcon.
  • • On January 18, 2013, ThromboGenics and Alcon have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending Jetrea® for the treatment of vitreomacular traction, including when associated with macular hole of diameter less than or equal to 400 microns. The EU MAA submission was based on data from two pivotal Phase III clinical trials that evaluated the safety and efficacy of a single administration of Jetrea®. Both studies met their primary endpoint and demonstrated that Jetrea® successfully resolved vitreomacular traction and macular holes compared to placebo. At day 28, 26.5% Jetrea-treated patients achieved resolution (versus 10.1% with placebo [P<0.001]). 72% of Jetrea® patients who achieved resolution of VMT and macular holes by Day 28, did so within seven days. All adverse reactions were ocular. The most commonly reported were vitreous floaters, eye pain and photopsia, as well as conjunctival haemorrhage resulting from the injection procedure. Most of the adverse reactions occurred within the first week after the injection. The majority of these reactions were non­serious, mild in intensity and resolved within 2 to 3 weeks.
  • • On January 4, 2013, ThromboGenics has confirmed its Jetrea® US launch date of Monday January 14th, 2013.
  • • On October 17, 2012, the FDA approved Jetrea® (ocriplasmin), the first drug approved to treat symptomatic vitreomacular adhesion. The safety and effectiveness of Jetrea® were established in two clinical studies involving 652 patients with symptomatic VMA. Patients were randomly assigned to receive a single injection of Jetrea into the eye or a substance without the active ingredient. Patients were evaluated over the next 28 days and for any side effects over the next six months. The studies found that VMA resolved in 26 percent of patients treated with Jetrea compared with 10 percent of those treated with the inactive product. These studies have been recently published in the New England Journal of Medicine. The most common side effects reported in patients treated with Jetrea® include eye floaters; bleeding of the conjunctiva, the tissue that lines the inside of the eyelids and covers the white part of the eye; eye pain; flashes of light (photopsia); blurred vision; unclear vision; vision loss; retinal edema (swelling); and macular edema. The recommended dose of Jetrea® is 0.125mg (0.1mL) of the diluted solution administered by intravitreal injection to the affected eye once as a single injection. Jetrea® is provided as a single use glass vial containing 0.5 mg in 0.2mL solution for intravitreal injection (2.5 mg/mL). ThromboGenics will commercialize the product itself in the U.S. The company is on target to build a first-class US commercial organization to launch Jetrea® in January 2013.
  • • On July 27, 2012, ThromboGenics has announced that the FDA Dermatologic and Ophthalmic Drugs Advisory Committee has recommended that the FDA grants ocriplasmin approval for the treatment of symptomatic vitreomacular adhesion. The Committee voted 10 to 0 at its meeting that the benefits of administering ocriplasmin for the treatment of vitreomacular adhesions outweigh the potential risks.
  • • On July 3, 2012, ThromboGenics has announced that the FDA has informed the company that it has officially accepted the filing of the BLA for ocriplasmin intravitreal injection, 2.5 mg/ml and granted it Priority Review. The FDA has already scheduled an Advisory Committee meeting on 26 July 2012 to discuss the ocriplasmin BLA. The FDA has assigned the ocriplasmin BLA a Prescription Drug User Fee Act (PDUFA) goal date of 17 October, 2012.
  • • On June 7, 2012, ThromboGenics has announced that the FDA has notified the Company that its new BLA for ocriplasmin intravitreal injection will be discussed at the Dermatologic and Ophthalmic Drugs Advisory Committee scheduled for July 26, 2012
  • • On April, 17, 2012, ThromboGenics announced that it has resubmitted a BLA with the FDA for ocriplasmin intravitreal injection, 2.5 mg/mL, for the treatment of symptomatic vitreomacular adhesion including macular hole.
  • • On February 2, 2012, ThromboGenics announces that the FDA intends to grant its recently-submitted ocriplasmin BLA for Priority Review. Consequently, ThromboGenics has withdrawn its current filing and will re-submit a BLA for ocriplasmin for symptomatic vitreomacular adhesion including macular hole by April 2012. The re-submission, for which the FDA is expected to grant a Priority Review, will allow ThromboGenics to meet the Pre-Approval Inspection timelines and to manage the phasing of its resources to support both its European and U.S. ocriplasmin filings.
  • • On December 23, 2011, ThromboGenics announced that it has submitted a Biologics License Application (BLA) with the FDA for ocriplasmin Intravitreal Injection, 2.5 mg/mL, for the treatment of symptomatic vitreomacular adhesion including macular hole. The BLA submission, includes data from two pivotal Phase III trials involving 652 patients in the U.S. and Europe.
  • • On October 19, 2011, ThromboGenics announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorisation Application for ocriplasmin (2.5 mg/ml, solution for injection) for the treatment of symptomatic vitreomacular adhesion including macular hole. The ocriplasmin MAA will be evaluated through the EMA’s Centralised Procedure with an official start date of October 19, 2011.
  • • On August 9, 2011, Thrombogenics has  announced that it expects to make the first ocriplasmin filing with the EMA in the next two months with the FDA filing taking place before year end.

Patents:

Submission of marketing authorization application USA : 2011-12-23 and 2012-04-17

Submission of marketing authorization application UE: 2011-19-12

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization: 2012-10-17

UE authorization: 2013-03-15

Favourable opinion UE: 2013-01-18

Favourable opinion USA: 2012-07-27

Orphan status USA:

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

  • • On September 18, 2017, ThromboGenics announced that it will regain full global rights to Jetrea® from Alcon, a Novartis company, based on a mutual agreement that the unique characteristics of Jetrea® make Thrombogenics a better fit for building a sustainable long-term niche business.

Is general: Yes