Charles River pens Takeda early-stage drugs deal

At the annual J.P. Morgan Healthcare Conference, major CRO Charles River Laboratories and Japanese Big Pharma Takeda announced a new preclinical tie-up.

The pair will “launch multiple integrated programs across Takeda’s four core therapeutic areas,” they said in a statement, namely: oncology, gastroenterology, neuroscience and rare disease, with Charles River being tasked with moving its preclinical candidates into the clinic and ultimately into the hands of patients.

This will be done by tapping Charles River’s drug discovery expertise and scientific bench, with the CRO using its end-to-end drug discovery and safety assessment platform to “explore potential therapeutic approaches and progress these programs towards candidate status.”

Takeda, which has been ramping up the deals with biotechs in recent years to help shore up its pipeline and progress with its core focus, will then have the option to push on with these early candidates through their clinical development pipeline.

Takeda will pay Charles River a one-time, upfront fee to establish the collab, though both stayed mum on what that dollar figure was. They did say Charles River will be in line to nab development payments with a potential value of over $50 million per program in preclinical and clinical milestones for those that will be put forward to a regulator.

The pact also includes additional potential commercial milestones of up to $120 million plus royalties on launched products, Takeda said.

James Foster, chairman, president and CEO at Charles River, said: “We are pleased to expand our relationship with Takeda, who shares our commitment to bring innovative, safe, and effective medicines to patients as quickly and efficiently as possible. We expect the expertise of Charles River and Takeda will prove to be a powerful combination in delivering novel drug candidates.”

https://www.fiercebiotech.com/cro/charles-river-pens-takeda-early-stage-drugs-deal

Iovance Biotherapeutics Shares Down 10% After Licensing Drug From Novartis

Iovance shares dropped 10% to $3.65 Monday after the company said it obtained a license from Novartis to develop and commercialize an antibody cytokine engrafted protein, referred to as IOV-3001.

The biotechnology company said it will make an up-front payment to Novartis as well as low single digit milestones involved in the initiation of patient dosing in various phases of clinical development for IOV-3001 and approval of the product in the U.S., EU and Japan.

Iovance said Novartis also is entitled to low-to-mid single digit royalties from commercial sales of the product.

Iovance said it will focus on manufacturing of IOV-3001 during 2020 and may initiate Investigational New Drug-enabling activities as early as 2021.

https://www.marketscreener.com/IOVANCE-BIOTHERAPEUTICS-36879287/news/Iovance-Biotherapeutics-Shares-Down-10-After-Licensing-Drug-From-Novartis-29830836/

Illumina, Roche Enter Partnership to Use Genomics for Medical Diagnosis

Illumina Inc. (ILMN) Monday said it entered a non-exclusive agreement with Roche to accelerate the use of genomics for medical diagnosis.

Illumina and Roche announced a 15-year, non-exclusive agreement to “broaden the adoption of distributable next-generation sequencing-based testing in oncology.”

Under the terms of the deal, Roche will receive rights to develop and distribute in-vitro diagnostic tests using Illumina technology, such as the NextSeq 550DX System. Illumina said Roche will develop, manufacture and commercialize AVENIO IVD tests for use on the NextSeq 550Dx System. Illumina will continue to sell the system and core sequencing consumables, it said.

Roche will also work to complement Illumina’s TruSight Oncology 500 pan-cancer assay, the companies said.

Financial terms of the deal weren’t disclosed.

https://www.marketscreener.com/ILLUMINA-INC-9659/news/Illumina-Roche-Enter-Partnership-to-Use-Genomics-for-Medical-Diagnosis-29830842/

Novartis Targets Large Scale UK Roll Out of Cholesterol Drug

Novartis AG (NOVN.EB) said Monday that it is aiming to ensure widespread access in the U.K. to its investigational cholesterol medicine Inclisiran as soon as it secures regulatory approval.

The Swiss drug maker said it wants to collaborate with the British government to ensure the supply and administration of the cholesterol-reducing drug to all eligible patients in the country’s National Health Service.

Inclisiran is currently in Phase 3 clinical study. The pharmaceutical company said it expects to file for marketing approval in the first quarter of this year. The first indication that is being sought is to provide the cholesterol-lowering drug to at-risk patients with atherosclerotic cardiovascular disease

Novartis gained the asset when it bought Medicines Co. in a $9.7 billion deal in November. The current roll-out plans are based on a memorandum of understanding that the acquired company signed with the U.K. government.

A company spokesperson said that the Swiss drug maker is engaged in talks to finalize the more detailed aspects of the agreement with British authorities.

Plans also include a new clinical trial for patients that are at a high-risk of having their first cardiac event.

https://www.marketscreener.com/NOVARTIS-9364983/news/Novartis-Targets-Large-Scale-UK-Roll-Out-of-Cholesterol-Drug-29830909/

SmileDirectClub prevails in legal challenge in New Jersey; shares up

The Superior Court of New Jersey has granted SmileDirectClub’s (SDC +9.3%) motion for summary judgment against the New Jersey Dental Association that claimed the company was illegally practicing dentistry in the state.

The court found that the allegations lacked merit.

https://seekingalpha.com/news/3531443-smiledirectclub-prevails-in-legal-challenge-in-new-jersey-shares-up-9

Incyte and MorphoSys Ink $1.1 Billion Immuno-Oncology Pact

MorphoSys AG and Incyte Corporation have inked a collaboration and license deal to further develop and commercialize MorphoSys’ anti-CD19 antibody tafasitamab around the world. Tafasitimab is a humanized Fc-engineered monoclonal antibody against CD19, which MorphoSys licensed from Xencor in 2010. It is being evaluated in B-cell malignancies in several ongoing combination trials.

The two companies will co-commercialize the drug in the U.S. and Incyte will market it outside of the U.S. Under the terms of the deal, Incyte will pay MorphoSys $750 million up front. It will also make an equity investment into MorphoSys of $150 million in American Depositary Shares (ADS) at a premium to the share price.

The deal could hit up to $1.1 billion based on various developmental, regulatory and commercial milestones. MorphoSys is also eligible for tiered royalties on U.S. net sales of tafasitamab outside the U.S. in the mid-teens to mid-twenties percentage range.

“The global partnership with Incyte is an important step towards unlocking the full potential of tafasitamab and achieving our goal of rapidly bringing tafasitamab to patients inside and outside the U.S.,” said Jean-Paul Kress, MorphoSys’ chief executive officer.

Kress added, “The combination of our strong antibody and drug development expertise partnered with Incyte’s well-established hematology-oncology experience and their commercial operations in key territories has the potential to significantly broaden the tafasitamab opportunity. We are pleased to work with Incyte to jointly improve the lives of patients suffering from DLBCL and other devastating diseases.”

The two companies will co-develop the drug in relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL), frontline DLBCL and in other indications such as follicular lymphoma (FL), marginal zone lymphoma (MZL) and chronic lymphocytic leukemia (CLL). Incyte will initiate a combination trial of its PI3K-delta inhibitor parsaclisib and tafasitamab in r/r B-cell malignancies. Incyte will also handle any potential registration-enabling studies in CLL and a Phase III study in r/r FL/MZL.

MorphoSys will continue to run it ongoing clinical trials of tafasitamab in non-Hodgkin lymphoma (NHL), CLL, r/r DLBCL and frontline DLBCL. They will split responsibilities for any additional global trials. Incyte also plans to work on development in other territories including Japan and China.

Morphosys recently submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for tafasitamab in combination with lenalidomide for r/r DLBCL. The target action date is mid-2020. It is also planning a similar application to the European Medicines Agency (EMA) for mid-2020.

“Bringing together Incyte’s expertise and MorphoSys’ commitment to innovation will allow us to make tafasitamab widely available to patients with cancer, upon approval,” said Herve Hoppenot, chief executive officer of Incyte. “We look forward to collaborating closely with the team at MorphoSys and adding tafasitamab to our portfolio of oncology candidates as part of our commitment to bringing new, advanced treatment options to patients and the clinical community around the world.”

https://www.biospace.com/article/incyte-and-morphosys-collaborate-on-immuno-oncology-program/

Abeona launches pivotal study of RDEB gene-corrected cell therapy

Abeona Therapeutics (ABEO -4.3%) initiates a randomized Phase 3 clinical trial, VIITAL, evaluating gene-corrected cell therapy EB-101 in up to 15 patients with a rare inherited skin blistering disorder called recessive dystrophic epidermolysis bullosa (RDEB).

The primary endpoint is the proportion of wounds with greater than 50% healing at month 3 compared to untreated wound sites on the same patient.

Dosing should commence this quarter.

https://seekingalpha.com/news/3531419-abeona-launches-pivotal-study-of-rdeb-gene-corrected-cell-therapy