Calliditas and PDUFA date of the 15th Sept 2021

Discussion in 'Stock Market Today' started by anexus, Jul 15, 2021.

  1. anexus

    anexus New Member

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    Nefecon is the first potential drug for IgAN, an orphan disease with a blockbuster potential of 4-5 billion USD. The European market is around half the potential of the US and China also appears to be an interesting market, however not an Orphan in China.

    With Approved priority review from FDA, very good security profile and orphan disease we expect it to be approved on the PDUFA date September 15th. The consensus target price (Base case) is 50 USD and does not include European or Chinese sales with conservative prices on Nefecon.

    Owner picture: BVF Partners is the largest shareholder with 12,7% of Calliditas. (US specialised biotech fund) Bengt Julander is the founder of the company and holds +10% of the company. Renée CEO owns shares for 5M USD+

    Stock: Low volume and almost no free float in USA, since only BVF and other institutional owners hold US shares, arrowstreet capital is short +0,6% of total shares. Currently trading UNDER bear case.

    Competitors: Omeros, Novartis and is many years behind Calliditas. The first competitor on the horizon is Omeros who are at least two years behind and is not an oral formulation as Nefecon, which significantly impacts the potential sales opportunity. Novartis is another oral drug but is yet to start their Phase 3, likely 4-5 years behind Calliditas.

    Calliditas has also met all primary endpoints.
     
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  2. ToBioOrNotToBio

    ToBioOrNotToBio New Member

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    Must be one of the safest bets at this time. Low volume traded makes an interesting short squeeze opportunity. All analysts bullish. Could be the next Orphazyme race, with one exception They will get Their FDA approval. LOA 95% +
     
  3. anexus

    anexus New Member

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    Still some time left, but easy minimum 20-40 % from here.
     
  4. anexus

    anexus New Member

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    Calliditas and STADA partner to bring a specialty therapy focused on downregulating IgA1 to European patients. If approved, it would be the first-ever approved treatment in the EU for chronic autoimmune kidney disease IgA Nephropathy (IgAN) · Partnership for this oral orphan-drug candidate combines Calliditas’ drug-delivery expertise with STADA’s pan-European marketing and sales expertise, including for specialty and nephrology medicines · Deal covering European Economic Area (EEA) member states, Switzerland and the UK is valued at a total of 97.5 million EUR ($115m), plus royalties Stockholm, Sweden; Bad Vilbel, Germany. 21 July 2021 – Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) and STADA Arzneimittel AG (“STADA”) announced today that they have entered into a license agreement to register and commercialize a novel specialty drug candidate for the treatment of the chronic autoimmune kidney disease Immunoglobulin A Nephropathy (IgAN) in the European Economic Area (EEA) member states, Switzerland and the UK.


    Under the terms of the agreement, Calliditas is entitled receive an initial upfront payment of 20M EUR ($24m) upon signing and up to an additional 77.5M EUR ($91m) in future payments linked to pre-defined regulatory and commercialization milestones. STADA is also obligated pay tiered royalties on net sales expressed as a percentage between the low twenties and the low thirties.

    The partnership relates to a novel oral formulation, developed under the project name ‘Nefecon’, of a potent and well-known active substance – budesonide – designed to target down regulation of IgA1 with a view to be disease modifying. If approved, this value-added specialty medicine, which received an EU orphan-drug designation in 2016, would be the first treatment authorized in the European Union for IgAN, a rare autoimmune disease. IgAN, also known as Berger´s disease, is a serious progressive autoimmune disease in which up to 50% of patients end up at risk of developing end stage renal disease and thus requiring dialysis or a kidney transplant. Prevalence in Europe is estimated at 4 in 10,000, translating into approximately 200,000 patients.

    “We are excited to be entering into this partnership with STADA to bring this IgAN therapy to market in Europe, where there is a significant unmet medical need for this patient population. We look forward to working in close collaboration with STADA to pursue marketing authorization with the goal of bringing the first ever EU-approved medication in IgAN to patients as soon as possible, utilizing STADA’s extensive marketing and sales platform throughout Europe,” said Renée Aguiar-Lucander, CEO of Calliditas.

    “This partnership, which leverages Calliditas’ drug-delivery expertise and clinical data in this under-served patient population, further validates STADA’s position as a go-to-partner for specialty pharmaceuticals, as well as for generics and consumer health products,” commented STADA CEO Peter Goldschmidt. “This value-added novel formulation for a large orphan indication will complement STADA’s offerings in nephrology, where we have built strong expertise over more than a decade through our epoetin zeta biosimilar and where we continue to place a clear strategic focus on seeking further opportunities to bring new options to patients.”

    The novel formulation is designed to deliver the drug to the Peyer’s patch region of the lower small intestine, where the disease originates as per the predominant pathogenesis models. The formulation uses a unique two-step technology, which allows for the substance to pass through the stomach and intestine without being absorbed, and to be released in a pulse like fashion only when it reaches the ileum in the lower small intestine. In addition to its potent local effect, another advantage of using this active substance is that it has very low bioavailability, with around 90% being inactivated in the liver before it reaches the systemic circulation. This means that a high concentration can be applied locally where needed, whilst limiting systemic exposure.

    On May 28, 2021, Calliditas announced that the company had, under the drug-development candidate name Nefecon, submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for a novel oral formulation of budesonide targeting down regulation of IgA1 for the treatment of primary IgAN. The company also filed an application for accelerated approval in the US on March 15, 2021 and was granted priority review in April 2021. The commercial brand name for this therapy in Europe will be determined and disclosed at a later date.

    Calliditas´ oral formulation has been granted Accelerated Assessment procedure by the Committee for Human Medicinal Products (CHMP) within the European Medicines Agency, which is intended to expedite access to drugs that the CHMP considers to be of major therapeutic interest from the point of view of public health and in particular from the viewpoint of therapeutic innovation. Accelerated assessment reduces the maximum timeframe for review of the MAA to 150 days (excluding clock-stops).

    IgAN is designated as an orphan disease in both the US and Europe. In Europe, an orphan disease is defined as a disease or condition affecting no more than five in 10,000 European citizens with no satisfactory method of diagnosis, prevention or treatment. Orphan incentives consist of ten years of market exclusivity from the grant date of marketing approval in the EU, protocol assistance and scientific advice, fee reductions on EMA procedural activities and eligibility for EU grants.

    If approved, the product could be available to patients in Europe in the first half of 2022 and would become the first therapy specifically designed and approved for the treatment of IgAN, and which has the potential to be disease modifying.
     

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